Archive for the ‘Anesthesia Drugs’ Category

Last year, The American Society of Anesthesiologists strongly urged a federal investigation into the drug shortage problem in the U.S. healthcare system. That led to The House Energy and Commerce Health Subcommittee holding a hearing in the fall they called “Examining the Increase in Drug Shortages.” Since then, there has been considerable legislative headway.

Last month, The U.S. House of Representatives overwhelmingly passed the final version of legislation that includes important provisions that address drug shortages.

S.3187, also known as the “Food and Drug Administration (FDA) Safety and Innovation Act,” was written to reauthorize the operations of the FDA’s prescription drug user fee program, which allows the FDA to collect fees from drug manufacturers to support the agency’s operations. Lawmakers, with the urging of the ASA and other advocates, also used the legislation to address drug shortages by including a section with provisions to prevent and mitigate the shortages.

Title X of the legislation requires drug manufacturers to notify the FDA when certain drugs are expected to stop being produced. This includes drugs used in the “treatment of a debilitating disease or condition” and pain drugs used in surgery (anesthesia).

The Food and Drug Administration (FDA) Safety and Innovation Act also include provisions to:

- Direct the Secretary of Health and Human Services to establish a task force to improve the response to drug shortages and create a plan to address aspects of shortages.

- Require the FDA to maintain a drug shortage list and provide it to patients, providers and the public.

- Authorize the Government Accountability Office (GAO) to conduct a study to examine the reasons for drug shortages and give recommendations on how to prevent or alleviate the shortage. This includes data on how the regulatory framework, manufacturing challenges, or other factors contribute to drug shortages, and recommendations to address issues.

Now it’s just up to the Senate to pass the legislation and the President to sign it.

According to the American Society of Anesthesiologists, its urging for a serious investigation into the drug shortage problem is paying off as the U.S. government is going to heed its call.

The House Energy and Commerce Health Subcommittee held a hearing on September 23 referred to as “Examining the Increase in Drug Shortages.” Members of the Drug Shortage Summit Legislative and Regulatory Work Group were among those testifying before a Congressional panel. The group, which formed November of 2010, functions as a coalition to advance drug shortage solutions.

On September 26, the Food and Drug Administration held a workshop open to the public on drug shortages. ASA Vice President for Scientific Affairs, Arnold Berry, M.D. presented a report on the impact drug shortages are having on anesthesiologists and their patients.

In April, the ASA took a survey to keep anesthesiologists and the public abreast on what is going on with drug shortages and how it’s impacting doctors and patients. Here are some of the highlights:

- 90.4 percent of respondents say they are currently experiencing a shortage of at least one anesthesia drug.

- 98.1 percent of respondents say they have had a shortage of at least one anesthesia drug in the last year.

- The anesthesia drugs with the highest frequency of reported current shortage are Neostigmine (56.9%), Thiopental (54.7%), Succinylcholine (47.6%), and Propofol (40.3%)

- The anesthesia drugs with the highest frequency of reported shortage over the last year are Propofol (89.3%), Succinylcholine (80.4%), and Thiopental (60.2%)

How has the shortage effected patients? According to the survey:

- 49.2 percent of patients did not experience an optimal outcome, which meant post-op nausea and vomiting.

- 49.1 percent of patients experienced longer OR or recovery times

Respondents said that drug shortages had the following impacts on their practice:

- 91.8 percent had to use alternative drugs
- 51.1 percent had to change the procedure in some way
- 6 percent had to postpone cases
- 4.1 percent had to cancel cases

Earlier this month an FDA advisory panel met regarding a very important topic: whether or not anesthesia poses cognitive and learning disability risks when used in young children. Since this involves millions of medical procedures, the importance of this topic is pretty obvious.

There have been a number of animal studies on the subject which have led to this meeting. According to Dr. Bob Rappaport, the Food and Drug Administration’s director of the division of anesthesia and analgesia products, these studies have suggested that there may be a correlation between anesthesia exposure and brain cell death or learning problems.

The FDA panel will evaluate this research, consider what further research may be needed, and decide what if anything parents should be presented if their children will be going into surgery.

“How do we communicate what we do know at this point without causing undue concern in parents and in physicians?", asked Dr. Rappaport.

Taking a look at the animal studies more closely, rodents and monkeys that were exposed to anesthesia at an age that is roughly equivalent to children under the age of four experienced brain cell death. An additional study, one done by the FDA, found that exposing newborn rhesus monkeys to 24 hours of anesthesia resulted in poorer tests performances for memory, attention and learning.

"We don’t know what this means for children at this time," said Dr. Rappaport. "That’s exactly why it’s so critical that we get all of the necessary information."

It’s difficult to do similar controlled studies with children, so when examining humans, experts look to children who have learning disabilities and trace back to see if they had anesthesia when they were younger. However, this method is not considered very reliable.

In the absence of absolutely certain evidence, ultimately the dilemma is this: most young children who are being given anesthesia absolutely need the surgery performed on them. So, what do you do?

“What we know is that not giving anesthesia and appropriate medication to manage a child’s pain during surgery does have long-term adverse affects on a child – physical as well as emotional,” said Dr. Jayant Deshpande, another committee member, pediatrician and anesthesiologist who is a senior vice president at Arkansas Children’s Hospital. “So because the child needs surgery today, we are going to use the best information that we have and use the anesthetics.”

Most of the studies so far the studies have involved the common anesthetic, ketamine. Some of the questions experts still have involve dose, age or length of exposure, and how each may relate to the risks.

We recently told you about the concerns over pain killng drug shortages. The issue is serious enough to have been addressed in Congress. Senator Amy Klobuchar of Minnesota and Bob Casey of Pennsylvania introduced legislation that would give the FDA the ability to require early notification from pharmaceutical companies when an issue may arise that could cause a shortage.

The next development continues to grow dire as 13 states are jointly requesting help from the federal government on how to acquire the anesthetic sodium thiopental. However, the states’ requests aren’t based on saving lives; it’s for ending them. Sodium thiopental is used as part of a lethal execution drug, however it is also used for brief surgical procedures. The shortage may force states to postpone executions. There have also been situations where states have sought alternatives, such as in Oklahoma where they used an anesthetic commonly used to euthanize animals to execute a prisoner.

Oregon is one of the 13 states that is signing the letter to the federal government. The other states signing the letter are Alabama, Colorado, Delaware, Florida, Idaho, Mississippi, Missouri, Nevada, Tennessee, Utah, Washington and Wyoming.

While the headlines are being dominated by the need for this drug in the justice system, what can’t be lost is that a shortage of anesthesia drugs has serious life-changing implications in the medical world.

"Never before have the shortages of key drugs been so prevalent," says Sheldon S. Sones, RPh, FASCP, president of Sheldon S. Sones and Associates, a pharmacy and accreditation consulting firm based in Newington, Connecticut. "While the best strategy is to keep as far ahead of anticipated supply needs as possible, borrowing non-controlled drugs may be an option."

Sometimes shortages are sudden and unpredictable, which is all the more reason that the drug shortage needs to be addressed on a national level, whether through legislation or other means.

Another reason is that, while some states are importing drugs like thiopental, there is uncertaintly about its safeness. Unfortunately, the messenger of this concern right now is a group of death row inmates who are suing to have the imported drugs halted. While the messengers may not be popular, the message is something worth considering.

The thought that there could be a shortage in pain killing drugs for the people who need them (doctors) is stunning and frankly hard to imagine. But surgeons are seeing shortages in everything from morphine to propofol, and this means they have to alter their treatment plans for patients by using alternative drugs. The American Society of Health-System Pharmacists lists 150 "medically necessary" drugs in the shortage crisis.

"It’s been going on for a number of years, but right now it seems to be a little worse than usual," said Dr. James Novotny, a medical oncologist at Franciscan Skemp.

The most important question is why is this happening? Pharmaceutical experts believe it comes down to business decisions made by drug companies. Some drug companies are choosing to increase production of the more profitable name brand drugs while cutting back on the production of generics.

Senator Amy Klobuchar of Minnesota took up the cause last December, vowing to introduce legislation that would provide the FDA with tools to address drug shortages. And she’s following through, with an announcement from her website that says she and Bob Casey (D-PA) have introduced a bill that gives the FDA the ability to require early notification from pharmaceutical companies when an issue may arise that could cause a shortage.

The duo’s proposed legislation is supported by the Minnesota Hospital Association, the American Hospital Association, Fairview Hospital, the American Society of Clinical Oncologists, and the Institute for Safe Medication Practices.

While herbal medicines may have once been seen as something relegated to counterculture types years ago, it’s very much a part of the mainstream in the U.S. today. Every year, Americans are spending over $27 billion on herbal supplements to help them with everything from memory to energy boosting.

While herbal medicines can often be used effectively, the term "natural" often gets mixed up with automatically being safe. This can be a potentially fatal assumption with people who have a surgical procedure where herbal products can interact adversely with anesthesia medicine. What anesthesiologists are finding is that many time patients aren’t revealing the use of herbal medications before they go into surgery.

According to a report at the American Society of Anesthesiologists, about half of all patients do not tell their doctors about their herbal supplement use before going under anesthesia.

"There is a clear gap in communication between doctors and patients on the topic of alternative medicines," says Dr. Rafael Ortega.

It’s unclear why the information is not being divulged, whether it’s embarrassment or not understanding how potent the medicine is that they are taking.

Since herbal drugs are not subject to the same standards under the Food and Drug Administration, it is not always clear how the compounds may interact with medicines used by doctors. In fact, manufacturers do not have to prove efficacy or track the side effects of their herbal products.

The chairman of the Department of Anesthesiology at Boston Medical Center Dr. Keith Lewis, a pharmacist and physician, recommends that patients stop taking herbal medicines at least two weeks before their surgical appointment. He also prefers patients bring in their medications for their doctors to examine.

Propofol, administered intravenously in operating rooms as an anesthetic and sedative, made its way into the spotlight in the last year or so thanks to the controversy over Michael Jackson’s overdose death. Now authorities are taking notice. The Drug Enforcement Administration was petitioned in 2009, according to DEA spokesman Rusty Payne, to designate propofol as a "scheduled" drug. This would create tighter restrictions on its distribution and use. However, Payne says that the petition was not related to propofol’s involvment in Michael Jackson’s death.

The Drug Enforcement Administration was petitioned in 2009, according to DEA spokesman Rusty Payne, to designate propofol as a "scheduled" drug. This would create tighter restrictions on its distribution and use. However, Payne says that the petition was not related to propofol’s involvment in Michael Jackson’s death.

However, the concern is rooted in worries of potential abuse of the powerful pain killer. Propofol is administered intravenously in operating rooms as an anesthetic and sedative.

Last fall, the DEA started circulating a proposed rule that would classify propofol as a Schedule IV substance. This puts it in the same category as midazolam, diazepam, lorazepam and zolpidem.

While DEA agent Rusty Payne says that he had no knowledge of propofol being abused on a large scale, having it classified as a Schedule IV substance puts it alongside drugs that are. The DEA also declined to provide a copy of the proposed rule for propofol, but looking at the statement for the sedative fospropofol, which was given Schedule IV status in 2009, propofol is mentioned:

“The current abuse profiles of propofol, the active metabolite of fospropofol, indicate that propofol is abused… The oral activity of fospropofol increases the likelihood of its abuse by other routes of administration and its use to commit other crimes (e.g., date rape).”

Chris Phillips.

Hi There! My name is Chris Phillips and I am the President of MBA Medical Business Associates, a medical practice management company specializing in anesthesia billing & improving practice management efficiency for anesthesiologists.